The ISO 13485:2016 training course presents a key market opportunity for medical device organizations to enhance their quality management systems, ensuring compliance with industry and regulatory ...

The Food and Drug Administration (FDA) issued a Final Rule to amend device current good manufacturing practices (CGMP) requirements of the Quality System (QS) regulation to harmonize the requirements ...

On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...

The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...

CLEVELAND--(BUSINESS WIRE)--KeborMed, the connected care platform, announced today it attained the ISO 13485 certification for its quality management system. This milestone marks a significant step in ...

This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the ...

Amend Surgical, a medical device company focused on novel products for oral wound-care and regenerative biomaterials, today announced that it has achieved ISO 13485:2016 certification, the global ...

NASHUA, N.H., July 27, 2011 /PRNewswire/ -- Mass Design Incorporated has been awarded ISO 13485:2003 certification by the International Standards Organization (ISO), enhancing this printed circuit ...

SAN DIEGO, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (BIOR) (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today announced it has been awarded ISO 13485:2016 ...

PERKASIE, Pa.--(BUSINESS WIRE)--US BioDesign, a global leader in the production of biomedical textile structure components today announced that they have received their ISO 13485:2003 Certification.